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Sponsored by: |
Tufts Medical Center |
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Information provided by: | Tufts Medical Center |
ClinicalTrials.gov Identifier: | NCT00175097 |
To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects.
Condition | Intervention |
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Hypercholesterolemia |
Behavioral: Soy protein |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects. |
Estimated Enrollment: | 30 |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | May 2005 |
Recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. This discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.The aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. The intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Plasma LDL-C >120mg/dL, Free from chronic illness, Not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin E, diuretics or hormones), Post-menopausal women.
Exclusion Criteria:
Soy allergy, Smokers, Consuming >2 alcoholic drinks per day, Pre-menopausal women.
United States, Massachusetts | |
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | |
Boston, Massachusetts, United States, 02111 | |
Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine | |
Boston, Massachusetts, United States, 02111 |
Principal Investigator: | Alice H Lichtenstein, DSc | Tufts University (HNRCA) |
Study ID Numbers: | HL 58008-1785, RO1 HL-58008 |
Study First Received: | September 13, 2005 |
Last Updated: | September 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00175097 |
Health Authority: | United States: Institutional Review Board |
soy protein lipids lipoproteins |
apolipoproteins cholesterol endothelial function |
Metabolic Diseases Hyperlipidemias Metabolic disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |